Exercise Resistance in Type 2 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Exercise

• Registration Number: NCT01911104
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

The purpose of this study is to collect data to help researchers identify factors that prevent certain individuals from receiving the beneficial effects of exercise.

Detailed Description

STUDY OBJECTIVES/ENDPOINTS

1. The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis measured using 31P magnetic resonance spectroscopy (MRS).

2. The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function in vivo and exercise mimetic-induced changes in mitochondrial function in vitro.

3. The principal tertiary endpoint is the relationship between the basal promoter methylation status of key genes involved in fuel metabolism and known to be activated by exercise in skeletal muscle tissue and cells and the exercise-induced response in mitochondrial function.

As exercise has an array of metabolic effects, and we are well positioned with our cutting-edge methodologies here at the Translational Research Institute (TRI), we will also measure whole body insulin sensitivity and metabolic flexibility by hyperinsulinemic-euglycemic clamp, substrate oxidation and energy expenditure in the whole room calorimeter/metabolic chamber and intramyocellular lipid content.

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-30
• Study Start: 2013-10-31
• Primary Completion: 2017-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	10 weeks of aerobic exercise

Primary Outcome Measures

Name	Time	Method
Change in ATPmax	Baseline and 10 weeks	The primary endpoint of the study is the maximal capacity for mitochondrial ATP synthesis (ATPmax) measured using 31P magnetic resonance spectroscopy (MRS).

Secondary Outcome Measures

Name	Time	Method
Change in in vivo and in vitro mitochondrial function	Baseline and 10 weeks	The principal secondary endpoint is the relationship between exercise-induced changes in mitochondrial function (ATPmax) in vivo and exercise mimetic-induced changes in mitochondrial function in vitro (maximal oxygen consumption of the human primary myotubes by the Oroboros® oxygraph).

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States